NALOXONE ACCORD 0.4 mg/mL injectable solution in pre-filled syringe

2. What you need to know before you are given Naloxona Accord

Naloxona Accord must not be administered:

• If you are allergic (hypersensitive) to naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Naloxona Accord should not be used in infants weighing less than 4 kg.

Warnings and PrecautionsConsult your doctor or pharmacist before you are given naloxone. Special caution will be taken:

• If you have physical dependence on opioids(e.g., morphine), or if you have received high doses of these drugs (you may experience intense withdrawal symptoms after receiving naloxone due to too rapid reversal of the opioid effect; these symptoms can include high blood pressure, palpitations, severe breathing difficulties, or cardiac arrest).

• If you have any heart or circulatory problems(because it is more likely that side effects such as high or low blood pressure, palpitations, or severe breathing difficulties will occur).

Using Naloxona Accord with other medicines

Tell your doctor or pharmacist that you are using or have recently used or might use any other medicines.

• If you are taking analgesic medicationsuch as buprenorphine. The analgesic effect may be even more intense while you are being treated with naloxone. However, the reversal of unwanted effects, such as respiratory depression caused by buprenorphine, is limited.
• If you are taking sedativesas naloxone may have a less rapid effect.
• If you are taking any medicine that may affect your heart or circulation(e.g., medications for hypertension such as clonidine), including those not prescribed.

Using Naloxona Accord with alcohol

Tell your doctor if you have drunk alcohol. In patients with multiple intoxication (with opioids and sedatives or alcohol), naloxone may have a less rapid effect.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

There is limited information on the use of naloxone in pregnant women. During pregnancy, your doctor will weigh the benefits of naloxone against the possible risks to the embryo or fetus. Naloxone may cause withdrawal symptoms in the newborn.

Breastfeeding

It is not known whether naloxone passes into breast milk or whether the baby is affected by Naloxona Accord. Therefore, breastfeeding should be avoided for 24 hours after treatment.

Driving and Using Machines

After receiving naloxone to reverse the effects of opioids, you should not drive, use machinery, or perform any other activity that requires physical or mental effort for at least 24 hours, as the effects of the opioids may recur.

Naloxona Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free".

3. How Naloxona Accord is administered

The recommended doses are:

To reverse the unwanted effects of opioids:

Adults: 0.1 to 0.2 mg, if necessary, additional injections of 0.1 mg may be administered.Children: 0.01 to 0.02 mg per kg body weight, if necessary, additional injections of the same dose may be administered.

Diagnosis of opioid overdose or poisoning:

Adults: 0.4 mg to 2 mg, if necessary, injections may be repeated at intervals of 2 to 3 minutes. The maximum dose should not exceed 10 mg.

Children: 0.01 mg per kg body weight, if necessary, an additional injection of 0.1 mg per kg may be administered.

Reversal of unwanted effects of opioids in newborns whose mothers have received opioids:

0.01 mg per kg body weight; if necessary, additional injections may be administered.

To reverse the unwanted effects of opioids (in adults, children, and also in newborns), patients are monitored to check that the desired effect of naloxone occurs. If necessary, additional doses may be administered every one to two hours.

In elderly patients with heart or circulatory problems or in those receiving medications that may cause circulatory or heart disorders (e.g., cocaine, methamphetamine, tricyclic antidepressants, calcium channel blockers, beta-blockers, digoxin), naloxone will be used with caution as serious side effects such as rapid heart rate (ventricular tachycardia) and fibrillation have occurred.

Naloxona Accord should not be used in infants weighing less than 4 kg.

If you feel that the effect of Naloxona Accord is too strong or too weak, tell your doctor.

Method of administration

Naloxone will always be administered by intravenous or intramuscular injection or, after dilution, as intravenous infusion (over a long period). Naloxona Accord will be administered by your anesthesiologist or by a doctor with experience.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, naloxone can cause side effects, although not everybody gets them.

It may be difficult to know which side effects are caused by Naloxona Accord, as it is always administered after other medicines have been used.

The following side effects may be serious. If you experience any of the following, tell a doctor immediately:

Common: may affect up to 1 in 10 people

• Rapid heart rate

Uncommon: may affect up to 1 in 100 people

• Changes in the way your heart beats, slow heart rate

Rare: may affect up to 1 in 1,000 people

• Seizures

Very rare: may affect up to 1 in 10,000 people

• Allergic reactions (hives, nasal congestion or cold, difficulty breathing, angioedema, anaphylactic shock
• Fibrillation, cardiac arrest
• Fluid in the lungs (pulmonary edema)

Other side effects include:

Very common: may affect more than 1 in 10 people

• Nausea

Common: may affect up to 1 in 10 people

• Dizziness, headache
• Increased or decreased blood pressure (you may have a headache or feel dizzy)
• Vomiting
• If a very high dose is administered after an operation, you may feel excited and have pain (because the analgesic effects of the medicines you have received will be counteracted, as well as the effects on your breathing)

Uncommon: may affect up to 1 in 100 people

• Involuntary tremors, sweating
• Diarrhea, dry mouth
• Excessive breathing (hyperventilation)
• Irritation of blood vessel walls (after intravenous administration); local irritation and inflammation (after intramuscular administration)

Rare: may affect up to 1 in 1,000 people

• Tension

Very rare: may affect up to 1 in 10,000 people

• Discoloration and skin lesions (erythema multiforme)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Naloxona Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or label of the syringe after "EXP". The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Keep the syringe in the original packaging to protect it from light.

Shelf life after first opening of the package

After first opening of the package, the medicine should be used immediately

Shelf life after dilution

Chemical and physical stability have been demonstrated for 36 hours at 2-8°C and 25°C.

From a microbiological point of view, the dilutions should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless the dilution has been made in a controlled and validated aseptic environment.

Do not use this medicine if you notice a change in the color of the solution or visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Naloxona Accord

The active substance is naloxone hydrochloride. Each pre-filled syringe with 1 ml contains 0.4 mg of naloxone hydrochloride (as dihydrate).

The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), and water for injections.

Appearance and packaging of the product

Naloxona Accord is a clear and colorless solution for injection/infusion in a pre-filled syringe, practically free from foreign particles.

1 ml glass syringe with a tip cap, plunger stopper (gray bromobutyl rubber), and plunger rod (polypropylene). Graduations for 0.1 ml are present on the syringe cylinder.

The pre-filled syringe is provided with a needle (23 G; 30 mm), packaged in a Twist Box.

Package size: one pre-filled syringe and one needle.

Marketing authorization holder and manufacturerMarketing authorization holderAccord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est 6ª planta,

08039 Barcelona,

Spain

ManufacturerAccord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice

Poland

Or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040

Spain

Date of last revision of this leaflet: December 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es